Acute Effects of Transcutaneous Electrical Nerve Stimulation at Acupoints on Nociceptive Transmission: A Mechanism Study Using Pain-Related Evoked Potentials
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain-Related Evoked Potentials (PREPs)
研究概览
简要总结
The goal of this clinical trial is to learn if transcutaneous electrical nerve stimulation (TENS) applied to acupoints can modulate pain transmission and cortical processing in healthy adult volunteers. The main questions it aims to answer are:
- Does TENS at Zhongzhu (SJ3) and Hegu (LI4) change pain-related evoked potentials (PREPs)?
- Does acupoint electrical stimulation alter nociceptive pathways reflected by PREP waveform modulation?
Researchers will compare PREPs recorded before and after TENS at the two acupoints to see if TENS produces measurable effects on cortical nociceptive responses.
Participants will receive low-frequency TENS applied to Zhongzhu (SJ3) and Hegu (LI4), and undergo PREP assessments before and after the intervention to measure cortical responses to standardized noxious stimuli.
详细描述
This study aims to investigate the modulatory effects of transcutaneous electrical nerve stimulation (TENS) applied to acupuncture points on pain transmission and cortical processing in healthy adults. Pain-related evoked potentials (PREPs) will be used as the primary neurophysiological measure to examine changes before and after TENS applied to two clinically recognized analgesic acupoints, Zhongzhu (SJ3) and Hegu (LI4). A within-subject design will be adopted, and participants aged 18 years or older will undergo two experimental sessions in randomized order. Each session will include baseline PREP assessment, a 20-minute low-frequency TENS intervention at the assigned acupoint, and a follow-up PREP measurement. PREP waveform characteristics, including N2 and P2 amplitudes and latencies, will be analyzed to determine whether acupoint stimulation alters nociceptive transmission. Subjective pain reports and adverse responses will also be collected to assess tolerability. The findings of this research are expected to provide insight into the neurophysiological basis of acupuncture analgesia and contribute to the development of more refined acupoint-based electrical therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adult
- •20 years or older
- •The absence of chronic medical conditions
- •No history of drug allergies
- •No skin disorders
- •No current use of medications that could affect study outcomes
- •Participants maintain a regular daily routine
- •No history of substance or medication abuse
排除标准
- •History of malignant tumors
- •History of hand disorders
- •Has implanted cardiac pacemakers
- •Pregnancy
- •Any other condition that may interfere with the study procedures
研究组 & 干预措施
TENS Group
Acupoint TENS Intervention (TENS Group) Participants in this group received low-frequency transcutaneous electrical nerve stimulation (TENS) applied to clinically recognized analgesic acupoints, Zhongzhu (SJ3) and Hegu (LI4). Each participant completed two intervention sessions in a randomized order, with at least 48 hours between sessions. During each session, participants first underwent a baseline assessment of pain-related evoked potentials (PREPs), followed by a 20-minute TENS application delivered through surface electrodes placed directly over the target acupoint. The stimulation parameters included low frequency and low-intensity currents adjusted to a comfortable but perceptible level. Immediately after the stimulation period, participants received a follow-up PREP assessment to evaluate changes in nociceptive cortical processing. Subjective pain responses and any discomfort or adverse reactions were recorded throughout the procedure. The entire protocol was designed to deter
干预措施: transcutaneous electrical nerve stimulation (TENS) (Device)
TENS Group
Acupoint TENS Intervention (TENS Group) Participants in this group received low-frequency transcutaneous electrical nerve stimulation (TENS) applied to clinically recognized analgesic acupoints, Zhongzhu (SJ3) and Hegu (LI4). Each participant completed two intervention sessions in a randomized order, with at least 48 hours between sessions. During each session, participants first underwent a baseline assessment of pain-related evoked potentials (PREPs), followed by a 20-minute TENS application delivered through surface electrodes placed directly over the target acupoint. The stimulation parameters included low frequency and low-intensity currents adjusted to a comfortable but perceptible level. Immediately after the stimulation period, participants received a follow-up PREP assessment to evaluate changes in nociceptive cortical processing. Subjective pain responses and any discomfort or adverse reactions were recorded throughout the procedure. The entire protocol was designed to deter
干预措施: EEG machine (Device)
结局指标
主要结局
Pain-Related Evoked Potentials (PREPs)
时间窗: Participants were assessed at time points: prior to the intervention (baseline), immediately after TENS application
PREPs were recorded using the Neuro-MEP4 EEG system. Participants were seated comfortably in a quiet room and instructed to remain relaxed during the recordings. Surface electrodes were placed according to standard PREP protocols to capture cortical responses to standardized noxious electrical stimuli applied to the forearm. For each trial, multiple stimuli were delivered, and the resulting N2 and P2 components were averaged to improve signal reliability. The primary outcome measures included the peak amplitudes and latencies of the N2 and P2 waves, which reflect cortical processing of nociceptive input.
次要结局
未报告次要终点